Shortage of approved anesthetic prompts Oklahoma to OK pentobarbital; other states approached suppliers in the U.K.

Do bioethical considerations extend into the lives—and deaths—of the condemned?

On Dec. 16, John David Duty became the first death row inmate in the nation to have the sedative pentobarbital shot into his arm as part of the three-injection procedure followed by most states where capital punishment is enforced.

In just about everynews story since a federal judge in Oklahoma ruled that the state’s prison system could use pentobarbital—in response to a shortage of the standard anesthetic administered in lethal injections—the drug has repeatedly been labeled, foremost, as a common method for “putting down dogs.”

But pentobarbital has a long history with humans, too. The barbiturate was first used in 1912 in Germany to treat epilepsy—as an alternative to bromide—emerging as a medication in the United States about a decade later. Pentobarbital is also commonly used as a sleep aid and remedy for narcotic withdrawal.

However, the real question is whether pentobarbital would prevent someone from feeling the highly excruciating level of pain that would occur if a person was not adequately anesthetized. That is far from certain, according to legal scholar and human rights advocate Leonard Rubenstein, an associate faculty member at the Johns Hopkins Berman Institute of Bioethics.

“If we don’t know, then we shouldn’t use it,” Rubenstein said. “You can’t speculate under the Constitution that this won’t be severely painful.”

The three-injection procedure followed by most death penalty states begins with a shot of the anesthetic sodium thiopental. The second chemical injected is pancuronium, which paralyzes the muscles, including the diaphragm. (Oklahoma uses vecuronium bromide.) The final, heart-stopping drug that is administered is potassium chloride.

At least one study has concluded that a person subjected to that sequence of injections would experience the horror of suffocation and/or the searing pain of potassium chloride entering the bloodstream if adequate anesthesia was not administered.

Meanwhile, another study questioned how much sodium thiopental should be injected, given that some condemned inmates are longtime drug or alcohol users and are likely extremely agitated just before they are executed—and so might be harder to anesthetize.

Nonetheless, the Supreme Court upheld that sequence of injections in 2008, ruling by a 7-2 majority that the procedure would protect an individual from “cruel and unusual punishment” that the Constitution’s Eighth Amendment prohibits.

But because sodium thiopental is so scarce on the market right now—the sole manufacturer reports that it has lost its supplier of drug’s main ingredient—death-penalty states have been trying to buy doses from each other. California has put in a bulk order from abroad, and Oklahoma now uses pentobarbital.

While not commonly referred to as an anesthetic, pentobarbital is an established option in critical care for inducing coma to relieve intracranial pressure, and it is one of the drugs that doctors in Oregon can prescribe in accordance with the state’s Death with Dignity Act.

Both of those facts complicate the question of whether the barbiturate is a viable substitute for sodium thiopental. If pentobarbital can induce coma, then it will obviously prevent a person from feeling any pain that might follow, Rubenstein concedes. But neither of those established uses proves, specifically, that the chemical is a reliable anesthetic against extremely severe pain, according to Rubenstein.

So, is there a valid ethical issue here, or is the novel—although likely successful—use of pentobarbital in lethal injection merely another opportunity for lawyers representing Death Row inmates to request a delay, and opponents of capital punishment more broadly?

“No. That’s not what this is about,” Rubenstein said. “We need to take this very seriously.”

The attorney for Duty, and those for two other death row inmates in Oklahoma, had argued to the state that executions should be halted because pentobarbital has not been tested for efficacy in the three-drug procedure.

“The question from a legal point of view is likely whether the risk of harm from a drug that has not been studied in humans is too great to allow in these circumstances,” Rubenstein explained. “I don’t know of any precedent for using an unapproved drug on anyone, including inmates.”

The maker of sodium thiopental, Hospira, Inc., is said to be the only U.S. manufacturer, and news reports say that the Illinois-based pharmaceutical firm won’t resume production until 2011 at the earliest.

In a story by the Associated Press, the news organization reported obtaining a letter from the company to the governor of Ohio (that state and Washington execute the condemned with a single dose of sodium thiopental) in which Hospira’s vice president of clinical research and development wrote that “we do not support the use of its products in capital punishment procedures.”

Groping for doses

There are 35 death penalty states, and in California and Arizona, their prison systems have recently acquired doses manufactured in Britain—triggering opposition by the American Civil Liberties Union. California, which has more inmates awaiting execution than any other capital punishment state, has confirmed a recent order for 521 grams of sodium thiopental from a supplier in the U.K.

A convicted killer in Arizona who had been on death row for two decades was executed using sodium thiopental that the state’s attorney general confirmed was imported from the U.K. The British government, which is officially opposed to capital punishment, has since issued a ban on the exporting of sodium thiopental.

The U.K. company that makes the drug, Archimedes Pharma, says it does not export doses to the United States. The California Department of Corrections and Rehabilitation stated that it ordered the drug through a distributor.

A spokeswoman for the prison system told the Huffington Post last week that California is awaiting the shipment, which was being held for clearance by the F.D.A.